DOCUMANTATION
Every country has its own system and requirements in order to register a pharmaceutical
or veterinary product. Although the required documents and procedures vary quite
a bit most have many similar requirements for documents in order to ensure that
the product being registered meet their standards for efficacy, safety and quality.
To ensure quality standards are met, the appropriate regulatory authority in the
intended drug market may request documents about the drug in question such as the
COPP, FSC, Complete Registration certificates from other countries, Product Registration
Dossier and others.
Good Manufacturing Practices (GMP)
A good manufacturing practices certificate show that the pharmaceutical manufacturing
company has passed the inspection of the pharmaceutical regulatory body of that
country and meets the standards of good manufacturing practices as stated by the
WHO.
Certificate of Analysis (COA)
A certificate of Analysis is the document that shows the testing parameters of a
pharmaceutical product according to the Pharmacopoeia in which the product was tested
to adhere to. The COA shows each test and their correlating results alongside the
results the Pharmacopoeia allows. An overall result of whether the pharmaceutical
product passes or fails according to the Pharmacopoeia is listed at the bottom.
Certificate of a Pharmaceutical Product (COPP)
The COPP is the legal document that declares a certain manufacturing company is
legally allowed to sell their pharmaceutical product in the country they are producing.
When registering a pharmaceutical product overseas, the government body in charge
of approving the application will usually require a COPP to ensure that the product
is being sold as a commercial finished product in the country that is producing
it.
Free Sales Certificate (FSC)
A Free Sales certificate is similar to a COPP where it enables a manufacturing company
to list pharmaceutical products in which they can sell in the local market and internationally.
A FSC, however can list multiple products at the same time.
DOSSIER
A Dossier is required by most ministries in charge of the regulation of importation
to ensure the process the manufacturer uses to produce a pharmaceutical product
is an acceptable international standard. The Product Registration Dossier is a document
that describes all the technical data related to the production, raw materials,
standard, stability and quality of the products.The Dossier describes the origin,
testing procedures and quality control of all the active and inactive pharmaceutical
ingredients used in the production including their analysis.
The processing of the raw materials is described in detail including the process
controls and the critical steps of intermediates. A Flow Diagram is typically used
to show step by step the process the raw materials and excipients undergo in order
to obtain the final product. The analysis of the final product is described in detail
including the test results according to the pharmacopeia used for analysis. Full
short and long term stability studies are also included to ensure the products can
stand the test of time and the elements.